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Design Control and Risk Management Specialist
2 months ago
Insight Global is seeking a highly skilled Design Control and Risk Management Engineer to join our team. As a key member of our Combination Product Team, you will be responsible for supporting the development and commercialization of medical device and combination products.
Responsibilities:- Lead the creation of Device Development, Design Control, and Risk Management deliverables for assigned projects.
- Implement and ensure effective execution of Device Development Strategy, Design Control, and Risk Management activities for assigned projects.
- Proactively resolve project obstacles and challenges.
- Understand and apply regulatory/compliance requirements relative to design controls and risk management activities.
- Lead conversations with external suppliers.
- 10 years' experience in Medical Device.
- Combination Product/Drug Delivery experience, specifically with Auto Injectors.
- Design Control & Risk Management experience.
- B.A./B.S in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering or other types of engineering.
- Medical, dental, and vision insurance.
- HSA, FSA, and DCFSA account options.
- 401k retirement account access with employer matching.
- Paid sick leave and/or other paid time off as provided by applicable law.
At Insight Global, we are committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances.
